The prevalence of insomnia ranges from 10-40% of the population in the United States (30 to 120 million people) with similar rates reported worldwide. Hypnotics are the primary medical treatment for insomnia, yet significant adverse events limit their use. Behavioral treatments for insomnia are effective, but the labor force and expense required to deliver this treatment are difficult to scale to the broad population of insomnia sufferers. A large market need exists for a safe, effective, non-invasive, home-based, non-pharmaceutical treatment for insomnia. Frontal cerebral hypothermia, a patent-pending intervention designed to reverse the hyperarousal in the central nervous system found in insomnia patients, is proposed to meet this need. Cerjve was founded by Eric Nofzinger MD, a thought leader in the neurobiology of insomnia at the University of Pittsburgh, to commercialize such a device. A brain imaging study, funded by the Respironics Research Foundation, confirmed that the device reduced frontal hypermetabolism during sleep with associated increases in slow wave sleep in insomnia patients. A Phase I SBIR study demonstrated that the device produced dose- dependent improvements in EEG sleep measures of sleep latency and sleep efficiency in insomnia patients. Now, this Phase II SBIR renewal aims to perform industrial design and mechanical engineering research to develop a commercializable home-based device, then to perform a confirmatory analysis of the effects of the device on sleep latency and sleep efficiency in insomnia patients. In collaboration with Cerjve, industrial design will be performed by Smart Design and mechanical engineering by Acorn Product Development, leaders in their fields. Cerjve, under the direction of Dr. Nofzinger, will supervise the multi-center clinical trial. Individual sites will include Neurotrials in Atlanta (Russell Rosenberg, Director) and Pacific Sleep Medicine in San Diego (Milton Erman, Director). Centralized EEG sleep scoring will be performed under the supervision of Tom Roth, PhD. 100 insomnia patients will enter the randomized, cross-over, device-control, multi-center clinical trial. All patients will receive 2 baseline nights of EEG sleep studies, then 2 nights at both a neutral and active device condition, with order of presentation randomized across patients. The long-term goal of this SBIR Project, if confirmatory analyses are positive, is to commercialize this device for the treatment of insomnia. The commercialization plan developed by Cerjve's CEO, Erica Rogers, an experienced medical device executive, suggests a large commercial opportunity for the company driven by the large unmet need in the insomnia market. Funds from this Phase II SBIR will supplement and leverage significant financial commitments for this work from private investors and the venture capital community. PUBLIC HEALTH RELEVANCE: The prevalence of insomnia ranges from 10-40% of the United States population. Available treatments have significant adverse events or are not widely available. The availability of a safe, effective home-based medical device for the treatment of insomnia such as that proposed in this Phase II SBIR application would be expected to have a significant public health impact.